During the registration processes of chemicals and drugs, within the European Union, United States of America, and Japan the current screening methods being applied for direct immunotoxicity are part of general toxicity testing. These toxicity tests are based on animal models, mainly consisting of rats, mice, and rabbits. The use of these animal models has three main drawbacks, mainly being ethical, economical, and the required translation towards the human situation can lead to false-positive and false-negative results. First, these tests cause suffering of the animals involved, which leads to societal concerns. Second, at present within the EU approximately 40 thousand chemicals are awaiting the process of registration, evaluation, and authorization (REACH). The EU has neither the infrastructure nor the economical means to test all of these chemicals in animal models. Third, the limited predictive power of these animal models for human toxicity complicates the processes of risk assessment of chemicals and safety testing of drugs. It has been shown in many instances that animal tests do not accurately predict immunotoxicity in humans.
False positive tests prevent many potentially useful drugs from reaching the market. False negatives cause human toxicity, either during the clinical-(I-III), and after-market phases (IV) of drug testing, or even later. At these stages, several millions of euros may already have been invested in vain. On average, the process of testing a chemical or drug for toxicity or safety takes years. This is partially caused by the time-consuming nature of animal tests.
Therefore, at the authorities and the industries involved in toxicity testing of chemicals and drug, there is a need for toxicity tests that are, ideally, more accurate, affordable, faster, and have less ethical concerns.